Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in October 2011 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.
On 19 February 2002, orphan designation (EU/3/02/088) was granted by the European Commission to Pharmax Limited, United Kingdom, for colistimethate sodium for the treatment of Pseudomonas aeruginosa lung infection (including colonisation) in cystic fibrosis.
Pharmax Limited changed its name to Forest Laboratories UK Ltd in July 2002.
Treatment of Pseudomonas aeruginosa lung infection (including colonisation) in cystic fibrosis
|Orphan designation status||
|EU designation number||
|Date of designation||
Documents related to this orphan designation evaluation
EU/3/02/088: Public summary of positive opinion for orphan designation of colistimethate sodium for the treatment of Pseudomonas aeruginosa lung infection (including colonisation) in cystic fibrosis (PDF/118.76 KB)
First published: 08/01/2003
Last updated: 19/11/2011
EMEA/COMP/75/02 Rev. 3
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: